Es handelt sich um eine offene, prospektive, kontrollierte, randomisierte, multizentrische Studie der Phase II, die eine intra-individuelle Wirksamkeit und Verträglichkeit des Oleogel-S10 mit einer feuchten Wundauflage im Hinblick auf einen Beschleunigung der Epithelialisierung der Wunde nach der Entnahme von Spalthaut mit einander vergleicht.
Conditions
Interventions
Product Name: Oleogel - S 10
Pharmaceutical Form: Cutaneous suspension
INN or Proposed INN: Triterpene dry extract from birk cork
Current Sponsor code: TE
Concentration unit: % percent
Concentration t
Sponsors
Birken GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients may participate in the study if they have/are: •Patients aged 18-95 years who have provided written informed consent. •Patients requiring skin grafting due to burns, trauma, chronic venous ulcers, or surgical removal of cutaneous malignancies with a donor site expected to be between 8 and 200 cm2 on a non-articulated area. •Patient is prepared to comply with all study requirements, including the following: - Application of Oleogel-S10 on the SSG at every change of wound dressing; - Regular clinic visits during the treatment period, and follow-up period. •Negative pregnancy test of women of childbearing potential performed within 7 days prior to the start of treatment. •Women of childbearing potential must agree to use an effective method of contraception (Pearl-Index =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they have/are: •burns involving more than 15% of their total body area; •sepsis, haemodynamic instability requiring pressor support or positive blood microbiology cultures within 48h of surgery; •inhalation injury requiring artificial respiratory assistance; •requiring skin grafts following removal of suspicious skin lesions; •received treatment with systemic steroids during the 30 days prior to surgery; •uncontrolled diabetes or diabetic ulcers; •diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety, tolerance or efficacy; •previously skin grafts harvested from the area to be studied; •a skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial; •a history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in this trial; •known multiple allergic disorders; •taking, or have taken, any investigational drugs within 3 months prior to the screening visit; •undergoing investigations or changes in management for an existing medical condition; •not likely to complete the trial for whatever reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Wound reepithelialization of that part of the skin graft donor site, which is treated with Olegel-S10 compared to that part of the wound, which is covered by moist wound healing dressing alone during a treatment period of 14 days.;Secondary Objective: • Size of wound epithelialization • Touch sensitivity • Pruritus • Reconstitution of the skin 3 months after skin explantation ;Primary end point(s): The primary endpoint for the biometrical evaluation of the therapy is wound re-epithelialization of that part of the skin graft donor site, which is treated with Olegel-S10 (about 50% of the total wound size) compared to that part, which is covered by moist wound healing dressing alone. A blinded assessment of the efficacy is conducted by two independent experts using the macro-photographs of every day, when wound dressings were changed, and a final examination at day 14. In all assessments, the third part of the SSG wound that is in between the left and right parts is neglected. The decision which part of the SSG wound is more epithelialized than the other will be made by the two independent experts at each time point respectively. The more epithelialized part will be assigned a “1”, the other part a “0”. The experts assessing the progress of the wound epithelialization do not know which part has been treated with Oleogel-S10. In case the experts assign different results to a particular SSG wound, that assessment is not counted. Otherwise one gets a “0/1” result for each part of the wound at each time point, respectively. At the end of the investigation a total score will be calculated by summing the 0/1-scores for each time point and for each part of the wound, respectively. The higher total score for each SSG wound will give the final “winner” of the wound closure progress, either Oleogel-S10 or the wound dressing alone. | — |
Countries
Germany
Outcome results
None listed